MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222335
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices with this product code that were released to distribution.As reported in the complaint there were too many suture tails loaded onto the anchor per the product ifu, which resulted in the wire break.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.A non-conformance search was performed for this product code 222335-lot #l421871 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a rotator cuff repair/greater tuberosity repair surgical procedure, the surgeon implanted similar anchor loaded with mitek permatape.The surgeon then implanted above anchor, as a lateral row anchor, and attempted to load the permatape (attached to previous (medial row anchor), into this anchor - 2 x strands of tape (doubled over = 4 strands, as when it is loaded in the wire kite, being pulled through central bore of anchor) plus the 2 x strands of no.2 orthocord (already pre-loaded in anchor) this combined volume of tape was too thick for central bore of 6.5mm healix knotless anchor.It was reported that the tape/cord got stuck but when surgeon pulled harder, it was observed that the wire broke.The surgeon used red tab/wire kite, from previous anchor, to first load permatape, then the orthocord.The surgeon voiced displeasure that he had to do this, said that the healix anchor should be able to accept tape, as well as the resident orthocord.There was a 10 minute delay to procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 6.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8281639
• Report Number: 1221934-2018-54050
• Device Sequence Number: 16458598
• Product Code: MBI
• UDI-Device Identifier: 10886705023431
• UDI-Public: 10886705023431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 222335
• Device Lot Number: L421871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR